A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level : Randomised double-blind placebo-controlled trial

A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level : Randomised double-blind placebo-controlled trial - A clinical study for evaluating the efficacy of test food on the suppression of the elevation of postprandial blood glucose level

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036242

Enrollment

Registered

2019-03-18

Start date

2019-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Food containing test food + glucose 75 g, single ingestion [Wash out for 1 week] Food not containing test food + glucose 75 g, single ingestion Food not containing test food + glucose 75 g, single ing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females, aged 20 - 65 years old. 2) Subjects whose fasting blood glucose level is from 110 mg/dL to 125 mg/dL or two-hour blood glucose level after 75 g glucose loading is from 140 mg/dL to 199 mg/dL, and who are judged normal-high or borderline type as the state of glycemia by the principal investigator. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1) Subjects whose fasting blood glucose level is greater than or equal to 126 mg/dL and two-hour blood glucose level after 75 g glucose loading is greater than or equal to 200 mg/dL. 2) A medical history of malignant tumor, heart failure or myocardial infarction. 3) Currently undergoing treatment for any of the following chronic diseases: atrial fibrillation, cardiac arrhythmia, liver failure, kidney failure, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4) Subjects who currently taking medications (including herbal medicines) 5) Subjects who are allergic to medications and/or the test food related products. 6) Subjects with irregular life rhythms such as shift workers, irregular eating habits. 7) Subjects who are pregnant, breast-feeding, or planning to get pregnant. 8) Subjects who have been enrolled in other clinical trials within the last 4 weeks before the agreement to participate in this trial. 9) Subjects who are considered as ineligible to participate in the study by the physician.

Design outcomes

Primary

Measure	Time frame
Blood glucose *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.	—

Secondary

Measure	Time frame
Insulin *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.	—

Countries

Japan

Contacts

Public ContactFumiko Kase

Allegro Inc. Clinical trial promotion department

f-kase@bml.co.jp03-5363-6821

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026